FDA 510(k)

陶瓷股頭

K 號：K240452 · 2024-04-12

決定日期2024-04-12

產品代碼LZO

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器材摘要

Ceramic Femoral Head is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K240452. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ceramic Femoral Head?

Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K240452.

When did Ceramic Femoral Head receive FDA 510(k) clearance?

Ceramic Femoral Head received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240452.

Who is the listed applicant for Ceramic Femoral Head?

FDA 510(k) 記錄將 Microport Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ceramic Femoral Head?

The FDA product code for Ceramic Femoral Head is LZO.

其他以 Microport Orthopedics, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LZO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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